BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 7550949 · Received May 29, 2018

    Report

    Report Number
    1213643-2018-01712
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    August 4, 2010
    Report Date
    October 27, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL COMPOSIX MESH (DEVICE #1) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT ADVERSE EVENT, AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL COMPOSIX MESH (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL COMPOSIX MESH (DEVICE #2). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2009: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) BARD/DAVOL COMPOSIX MESH, REFERENCE NUMBER 0113480, LOT NUMBER HTG1012 (DEVICE #1) AND REFERENCE NUMBER 0113480, LOT NUMBER HUTE1242 (DEVICE #2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL COMPOSIX MESH (DEVICE #1 AND DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392386 MESH - COMPOSIX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUTG1012

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Disability| R